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Dermata (DRMA) Gains on Positive FDA Response for Acne Candidate
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Dermata Therapeutics (DRMA - Free Report) was up almost 12% on Apr 20, after receiving a positive FDA response for initiating phase III studies evaluating DMT310 for severe to moderate acne treatment. The company had submitted a chemistry, manufacturing, and controls (CMC) meeting request for phase III initiation to the FDA.
This news is a significant milestone for Dermata, as it means that the company's CMC procedures and controls have met the standards required by the FDA to advance its clinical program. The CMC meeting request guides the company on the next steps regarding its phase III clinical study program.
Additionally, DRMA has submitted an end-of-phase II meeting package to the FDA to discuss clinical requirements for advancing DMT310 into phase III development.
Dermata's shares have plunged 58.8% in the year-to-date period compared with the industry's 4.8% decline.
Image Source: Zacks Investment Research
Dermata's lead product candidate, DMT310, is a once-weekly topical treatment derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. In addition to acne, the drug has also been studied to treat psoriasis and rosacea. If the phase III program is successfully completed, Dermata believes that the results could support the submission of a new drug application for DMT310 to treat moderate-to-severe acne.
The company’s second product candidate, DMT410, uses Spongilla technology as a new method for needle-free intradermal delivery of botulinum toxin to treat multiple aesthetic and medical skin conditions.
The company expects a written feedback from the FDA by the end of June 2023, following the end of the phase II meeting package. Dermata plans to initiate the phase III program for acne in the second half of 2023 with due permission from the FDA.
The successful development of DMT310 would be a significant achievement for the company.
Loss per share estimates for CRISPR Therapeutics have narrowed from $8.21 to $7.22 for 2023 in the past 60 days.
CRSP's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, the average surprise being 3.19%. The company's shares have plunged 22.7% in the year-to-date period.
Loss per share estimates for Kala Pharmaceuticals have narrowed from $18.34 to $16.54 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. KALA's shares have plunged 58.9% in the year-to-date period.
The company's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.83 to $2.44 for 2023 and from $2.69 to $2.46 for 2024 in the past 60 days.
ALLO's earnings beat estimates in each of the trailing four quarters, the average surprise being 8.33%. The company's shares have plunged 20.7% in the year-to-date period.
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Dermata (DRMA) Gains on Positive FDA Response for Acne Candidate
Dermata Therapeutics (DRMA - Free Report) was up almost 12% on Apr 20, after receiving a positive FDA response for initiating phase III studies evaluating DMT310 for severe to moderate acne treatment. The company had submitted a chemistry, manufacturing, and controls (CMC) meeting request for phase III initiation to the FDA.
This news is a significant milestone for Dermata, as it means that the company's CMC procedures and controls have met the standards required by the FDA to advance its clinical program. The CMC meeting request guides the company on the next steps regarding its phase III clinical study program.
Additionally, DRMA has submitted an end-of-phase II meeting package to the FDA to discuss clinical requirements for advancing DMT310 into phase III development.
Dermata's shares have plunged 58.8% in the year-to-date period compared with the industry's 4.8% decline.
Image Source: Zacks Investment Research
Dermata's lead product candidate, DMT310, is a once-weekly topical treatment derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. In addition to acne, the drug has also been studied to treat psoriasis and rosacea. If the phase III program is successfully completed, Dermata believes that the results could support the submission of a new drug application for DMT310 to treat moderate-to-severe acne.
The company’s second product candidate, DMT410, uses Spongilla technology as a new method for needle-free intradermal delivery of botulinum toxin to treat multiple aesthetic and medical skin conditions.
The company expects a written feedback from the FDA by the end of June 2023, following the end of the phase II meeting package. Dermata plans to initiate the phase III program for acne in the second half of 2023 with due permission from the FDA.
The successful development of DMT310 would be a significant achievement for the company.
Dermata Therapeutics, Inc. Price and Consensus
Dermata Therapeutics, Inc. price-consensus-chart | Dermata Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Currently, Dermata has a Zacks Rank #3 (Hold).
Some better-ranked stocks for investors interested in the same sector are CRISPR Therapeutics (CRSP - Free Report) , Kala Pharmaceuticals (KALA - Free Report) and Allogene Therapeutics (ALLO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for CRISPR Therapeutics have narrowed from $8.21 to $7.22 for 2023 in the past 60 days.
CRSP's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, the average surprise being 3.19%. The company's shares have plunged 22.7% in the year-to-date period.
Loss per share estimates for Kala Pharmaceuticals have narrowed from $18.34 to $16.54 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. KALA's shares have plunged 58.9% in the year-to-date period.
The company's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.83 to $2.44 for 2023 and from $2.69 to $2.46 for 2024 in the past 60 days.
ALLO's earnings beat estimates in each of the trailing four quarters, the average surprise being 8.33%. The company's shares have plunged 20.7% in the year-to-date period.